Effect of an Advance Care Planning Intervention

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Advance Care Planning Video

• Registration Number: NCT04852055
• Lead Sponsor: Brown University

Brief Summary

The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.

Detailed Description

Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Results First Submitted: 2023-04-21
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Results First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2611

Inclusion Criteria

• Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
• Patients not on hospice
• Patients who do not have comfort care or do-not-hospitalize orders at baseline

Exclusion Criteria

• Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
• Patients on hospice
• Patients with comfort care or do-not-hospitalize orders at baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information	Advance Care Planning Video	Patients and proxies in assisted living centers randomized to the information arm will receive a letter from their clinician with a link to an educational video describing the goals of care and how specific treatment decisions align with these goals. Patients and proxies will also continue to receive usual care advance care planning conversations.

Primary Outcome Measures

Name	Time	Method
Do-Not-Resuscitate	4 months	Percentage of residents with do-not-resuscitate orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm

Secondary Outcome Measures

Name	Time	Method
Do-Not-Hospitalize	4 months	Percentage of residents in each arm with do-not-hospitalize or comfort care orders documented in the electronic health record at end of follow-up, comparison between usual care and experimental arm
Advance Care Planning Billing	4 months	Percentage of residents in each arm with current procedural terminology billing code for advance care planning during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting
Hospitalization	4 months	Percentage of residents with any inpatient hospitalization during follow-up based on Medicare claims data, comparison between usual care and experimental arm. Requires access to claims data which delays reporting

Trial Locations

Locations (1)

Bluestone Physician Services; 🇺🇸 Stillwater, Minnesota, United States